Androgenetic Alopecia, Female Pattern Baldness, Hair Loss, Hair Loss/Baldness
Conditions
Brief summary
The HairDx Test reports genetic variants associated with the development of FPHL.
Detailed description
The HairDx Test reports genetic variants associated with the development of FPHL. The variants are detected from a saliva sample collected at home. The HairDx Test report is designed to help individuals understand the meaning of their results and encourage a conversation with a healthcare professional. The information provided by the HairDx Test report is not intended to start, stop or change any course of treatment. The purpose of this study is to collect DNA samples from subjects. The DNA samples will be used for the analytical validation of the HairDx Test. The results of this study will not be shared with the subjects.
Interventions
DEVICEHairDx Sample Collection Kit
Saliva collection using FDA OTC cleared sample collection device
Sponsors
Applied Biology, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Inclusion criteria
* Females over the age of 18 * Overall good health * Able to give informed consent * Willing to collect saliva sample
Exclusion criteria
* Xerostomia (dry mouth) * Inability to provide informed consent in English * Inability to follow instructions for saliva sample collection * Non US resident
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of the accuracy of the HairDx Test | Baseline | Determination of the accuracy of the HairDx Test in comparison to bi-directional Sanger sequencing |
| Determination of the precision and reproducibility of HairDx Test | Baseline | Determination of the precision and reproducibility of HairDx Test in accordance with the laboratory instructions for use documentation |
Countries
United States
Outcome results
None listed